Safety Specialist

Catalyst Clinical Research, LLC; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

Catalyst Clinical Research is seeking a Safety Specialist to coordinate safety processes within the Flex Operations Safety Team. This critical role involves managing project compliance, training staff, and ensuring regulatory adherence while supporting project management activities. Candidates should have a background in healthcare or life sciences and a minimum of 2 years of clinical research experience with a CRO.

Qualifications

• 2 years of clinical research experience with a CRO.
• Healthcare professional licensure optionally required.
• Ability to analyze project data for accuracy.

Responsibilities

• Coordinate safety responsibilities for multiple programs.
• Assist with implementing reporting processes and training.
• Manage project compliance with contracts and regulations.

Skills

Knowledge of drug development

FDA regulations

ICH GCP guidelines

Global safety reporting requirements

Excellent communication skills

Analytical skills

Education

Healthcare or life science degree

Tools

Microsoft Office Suite

Job description

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Safety Specialist, you are a key member of the Flex Operations Safety Team and coordinate safety responsibilities for multiple programs, including staffing, training, and procedural compliance. You work with senior management to develop internal processes and ensure compliance.

The Safety Specialist liaises with the Project Manager and clients to ensure optimal team performance. They manage all aspects of projects, ensuring contractual, procedural, and regulatory requirements are met, and may serve as backup for project coverage. The role requires maintaining medical knowledge of therapeutic areas and disease states, and collaborating with Medical Monitors and CMOs to manage projects.

Position Responsibilities:

1. Assist with implementing reporting processes and coordinate with staff, third parties, and consultants to meet regulatory timeframes.
2. Assist in onboarding and training PV Safety Staff.
3. Support Project Management with PV input for meetings and financial matters.
4. Assist with revenue recognition and profitability reviews.
5. Complete Quality Events (QE) and CAPA related to PV system/process weaknesses or customer complaints.
6. Provide input on financial management of study budgets.
7. Support configuration of Safety Database, CTMS, EDC, and eTMF systems and draft SOPs.
8. Perform other responsibilities and ad hoc projects as required.

Education: Healthcare or life science degree; licensure as a healthcare professional (MD, RN, RRT, MLT) optional.

Experience: 2 years of clinical research experience with a CRO.

Required Skills:

• Knowledge of drug development, FDA regulations, ICH GCP guidelines, and their application.
• Knowledge of global safety reporting requirements, AE reporting, and safety submissions.
• Willingness to travel up to 25%.
• Ability to analyze project data and systems for accuracy and efficiency.
• Proficiency with Microsoft Office Suite.
• Excellent communication, presentation, organizational, problem-solving, and analytical skills.
• Ability to manage priorities, work independently, and handle multiple projects.
• Strong interpersonal skills and ability to work with diverse individuals.
• Commitment to high standards and excellence.
• Flexibility, creativity, and team-oriented attitude.
• Good judgment and timely decision-making skills.